Nivolumab denials: what the review data shows
Independent reviewers have decided 12 published cases where an insurer denied Nivolumab — and they overturned the insurer 8.3% of the time. A denial for Nivolumab is a starting position, not a final answer.
What the insurer actually argued
| Reason given | Decisions | Overturned |
|---|---|---|
Experimental/Investigational The plan called the treatment unproven. These turn on published evidence, so the appeal is a literature argument. | 7 | 0% |
Medical Necessity The plan said the care wasn’t medically necessary. The most common fight, and the most winnable. | 5 | 20% |
Where the denial was overturned
Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for immunotherapy. In this case, the patient has a history of metastatic kidney cancer which has spread to the right knee, and also a history of lupus vasculitis. It is not clear if the patient has clear cell or non-clear cell kidney cancer. However, both have immunotherapy treatment options including nivolumab and ipilimumab, pembrolizumab, or in combination with tyrosine kinase inhibitors. In patients with systemic lupus erythematosus complicated by vasculitis, the use of immunotherapy carries a significant risk of triggering disease flares or severe autoimmune complications. As such, immunotherapy is used with extreme caution in these patients, balancing cancer treatment benefits against the risk of autoimmune exacerbation.
Where the denial was upheld
Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Nivolumab (Opdivo) injections (CPT code J9299) 292.5 mg intravenous (IV) every 14 days for six cycles. The patient is not eligible for U.S. Food and Drug Administration (FDA) standard approved use of Opdivo, as he has microsatellite stable disease (Smith and Desai). The FDA supports treatment with Opdivo for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that “has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.” This patient has the standard care option of regorafenib for treatment of microsatellite stable disease. The recommendation for the combination of regorafenib with Opdivo is based on recent data from the phase 1b results of the REGONIVO trial.
Nature of Statutory Criteria/Case Summary: The parent of a male enrollee has requested authorization and coverage for immunotherapy with nivolumab (Opdivo). The Health Plan has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee’s grade IV glioblastoma. Although multiple trials are testing various forms of immunotherapy in patients with glioblastoma, published data remain limited. In a phase I trial investigating the safety of monotherapy or combination therapy with two checkpoint inhibitors, 40 patients received either Opdivo with or without ipilimumab. Overall, monotherapy with Opdivo was better tolerated than combination therapy. However, the authors concluded that further studies are needed to help select patients most likely to respond to checkpoint inhibitor immunotherapy.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California outcomes — every state runs an equivalent external review, but the rates here are California’s. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Nivolumabwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · DERIVED AGGREGATE STATISTICS ONLY · METHODOLOGY